Cytosorbents Corp Stock Price, News & Analysis

CytoSorbents (NASDAQ: CTSO) reported Q3 2025 revenue of $9.5M, up 10% year-over-year, with gross margin 70%. Operating loss improved to $2.9M and net loss was $3.2M ($0.05/share); adjusted net loss was $2.6M ($0.04/share). Cash and equivalents were $9.1M on Sept 30, 2025, proforma $11.6M assuming an additional $2.5M term loan.

The company amended its credit agreement to provide an immediate $2.5M term loan, extended interest-only to Dec 31, 2026, and issued 1,428,571 warrants at $0.70. Workforce reduction of ~10% and a restructuring charge up to $900k aim to reach operating cash-flow breakeven in Q1 2026. DrugSorb-ATR De Novo submission is planned in Q1 2026 with an anticipated decision by mid-2026.

CytoSorbents (NASDAQ: CTSO) said its CEO Dr. Phillip Chan and CFO Peter Mariani will attend the Jefferies Global Healthcare Conference in London on November 18-19, 2025.

Management will participate in one-on-one investor meetings; investors can schedule meetings through the conference website. For investor queries, contact the company investor relations team at ir@cytosorbents.com.

CytoSorbents (NASDAQ: CTSO) said it will report third quarter 2025 financial results and recent business highlights after the market close on Thursday, November 13, 2025. Management will host a live conference call, presentation webcast, and Q&A starting at 4:30 PM ET the same day.

Investors may join the live webcast at https://app.webinar.net/g7AGWegQ613. Participants are recommended to dial in about 10 minutes early. An archived recording will be available under the Investor Relations section at https://ir.cytosorbents.com/.

CytoSorbents (NASDAQ: CTSO) announced its upcoming scientific presentations at the European Association for Cardio-Thoracic Surgery (EACTS) Annual Meeting in Copenhagen, October 8-11, 2025. The event will showcase groundbreaking data for their blood purification technologies CytoSorb® and DrugSorb™-ATR in cardiac surgery applications.

Two significant presentations will be featured: The first randomized trial results of DrugSorb-ATR for removing direct oral anticoagulants during urgent cardiac surgery, and a real-world study showing CytoSorb's effectiveness in reducing bleeding complications in acute coronary syndrome patients undergoing CABG surgery. Additionally, a company-sponsored lunch symposium will discuss hemoadsorption as a safety net in cardiac surgery.

CytoSorbents (NASDAQ: CTSO) provided a regulatory update on DrugSorb-ATR, its FDA Breakthrough Device for blood purification. Following FDA's previous De Novo application denial, the company has received constructive feedback and will submit a new De Novo application with additional real-world data supporting their desired label indication for patients on ticagrelor undergoing urgent CABG surgery.

The FDA found no safety issues with the device and has proposed an expedited path for market authorization. CytoSorbents plans to file a pre-submission meeting request in October 2025, with a formal FDA meeting expected in Q4 2025. A regulatory decision is anticipated by mid-2026. Additionally, the company has withdrawn its Health Canada reconsideration request, planning to submit a new application after gaining clarity from the FDA process.

CytoSorbents Corporation (NASDAQ: CTSO) announces a global webinar titled "Turning the Tide in Sepsis and Septic Shock: Real World Insights with CytoSorb" scheduled for September 10, 2025, at 11:00 AM EDT. The webinar, hosted by CEO Dr. Phillip Chan, will feature international critical care experts sharing insights on using CytoSorb® blood purification therapy to treat sepsis and septic shock.

The distinguished panel includes experts from Switzerland, Hungary, and Germany who will discuss best practices for early and intensive CytoSorb treatment. The agenda covers how CytoSorb complements antibiotics, prevents organ failure, and achieves key treatment goals in sepsis, including controlling inflammation, stabilizing patients, removing toxins, and managing fluid overload.

CytoSorbents Corporation (NASDAQ: CTSO), a company specializing in blood purification for critical care and cardiac surgery, has announced its participation in the H.C. Wainwright 27th Annual Global Investment Conference. The presentation is scheduled for September 8, 2025, at 11:30 AM ET at the Lotte New York Palace Hotel in New York.

Investors can access the live presentation through a webcast, and a replay will be available for 90 days on the company's investor relations website.

CytoSorbents (NASDAQ: CTSO) received an FDA appeal decision regarding its DrugSorb-ATR device, following the April 2025 De Novo application denial. While the FDA found no safety issues with the device, they upheld the denial citing the need for additional information to support the label indication for this FDA Breakthrough Device.

The FDA has proactively proposed a potential path forward for market authorization, and the company continues discussions with the Agency. CytoSorbents has the option to file another appeal with the FDA's CDRH Director within 30 days. The device aims to help heart attack patients requiring urgent CABG surgery while on ticagrelor, addressing the critical issue of perioperative bleeding risk.

CytoSorbents (NASDAQ: CTSO) reported Q2 2025 financial results showing revenue growth of 9% to $9.6 million compared to Q2 2024, primarily driven by 22% growth in Germany. The company achieved a net income of $1.9 million ($0.03 per share) versus a net loss in Q2 2024, while maintaining a gross margin of 70.9%.

Key developments include an FDA appeal hearing for DrugSorb™-ATR, with a final regulatory decision expected in 2025, and continued work with Health Canada following their Notice of Refusal. The company's cash position stands at $11.7 million as of June 30, 2025. Management expects to approach breakeven operations by the end of 2025 through improved execution and cost control measures.

The company announced an upcoming World Sepsis Day Global Webinar on September 10, 2025, highlighting CytoSorb's role in treating sepsis and septic shock, supported by recent positive clinical studies and meta-analyses showing significant mortality reduction.